System and method for switching between medicament delivery control algorithms

ABSTRACT

Disclosed herein are systems and methods for safely switching between medicament delivery control algorithms for control of an ambulatory infusion pump or other medical device. Infusion pumps and/or remote control devices may be capable of operating different algorithms for delivery of medicament and provided herein are mechanisms for safely transitioning between algorithms.

RELATED APPLICATION

The present application claims the benefit of U.S. ProvisionalApplication No. 62/743,901 filed Oct. 10, 2018, which is herebyincorporated herein in its entirety by reference.

TECHNICAL FIELD

The present invention is directed to portable infusion pumps and moreparticularly algorithms for controlling portable infusion pumps.

BACKGROUND

There are a wide variety of medical treatments that include theadministration of a therapeutic fluid in precise, known amounts atpredetermined intervals. Devices and methods exist that are directed tothe delivery of such fluids, which may be liquids or gases, are known inthe art.

One category of such fluid delivery devices includes insulin injectingpumps developed for administering insulin to patients afflicted withtype I, or in some cases, type II diabetes. Some insulin injecting pumpsare configured as portable or ambulatory infusion devices can providecontinuous subcutaneous insulin injection and/or infusion therapy as analternative to multiple daily injections of insulin via a syringe or aninsulin pen. Such pumps are worn by the user and may use replaceablecartridges. In some embodiments, these pumps may also delivermedicaments other than, or in addition to, insulin, such as glucagon,pramlintide, and the like. Examples of such pumps and various featuresassociated therewith include those disclosed in U.S. Patent ApplicationPublication No. 2013/0053816, U.S. Pat. Nos. 8,573,027, 8,986,253, U.S.Patent Application Publication Nos. 2013/0324928, 2013/0331790, U.S.Pat. No. 8,287,495 and U.S. patent application Ser. No. 15/158,125, eachof which is hereby incorporated herein by reference in its entirety.

Ambulatory infusion pumps such as those described above are generallycontrolled by software algorithms running locally on an on-boardprocessor housed within the pump. Some pumps may include one or morealgorithms that can be utilized, including one or more open loopalgorithms in which the user primarily programs medicament deliveriesand one or more closed loop algorithms that automatically adjustmedicament deliveries based on, e.g., continuous glucose monitoring(CGM) data. A user may be able to switch among these algorithms and/orthe processor can be configured to automatically switch algorithms undervarious conditions. It is important when switching algorithms that thetransition between algorithms not result in either missed medicamentdeliveries or double medicament deliveries with two algorithms dosingbased on the same event.

In addition, with the proliferation of handheld electronic devices, suchas mobile phones (e.g., smartphones), there is a desire to be able toremotely utilize such devices, as well as dedicated wireless controllersdesigned to work with one or more infusion pumps and/or types ofinfusion pumps, to optimize usage of infusion pumps. These remotecontrollers would enable a pump to be monitored, programmed and/oroperated more privately, more conveniently and more comfortably.Accordingly, one potential use of dedicated remote devices and handheldconsumer electronic devices (such as smartphones, tablets and the like)is to utilize such devices as controllers for remotely programmingand/or operating infusion pumps.

Such remote control devices include internal memory, one or moreprocessors, etc. such that those devices would be capable ofindependently running one or more software algorithms for control of aninfusion pump alternatively or in addition to a software algorithm thatmay be operable on the pump itself. However, use of different softwarealgorithms that may be provided by, e.g., a third party not affiliatedwith the manufacturer of the infusion pump brings risk of the algorithmnot having critical patient data needed for proper therapydeterminations.

SUMMARY

Disclosed herein are systems and methods for safely switching betweenmedicament delivery control algorithms for control of an ambulatoryinfusion pump or other medical device. Infusion pumps and/or remotecontrol devices may be capable of operating different algorithms fordelivery of medicament and provided herein are mechanisms for safelytransitioning between algorithms.

According to embodiments, a pump and/or remote control device caninclude multiple different control algorithms for making therapydecisions for delivery of medicament with the pump that can beuser-selectable and/or automatically transitioned between by the device.Prior therapy data can be shared and/or accessed by a new controlalgorithm to ensure the new algorithm does not provide double doses orotherwise make dosing decisions inconsistent with prior therapy. Asupervisory control algorithm can also be provided, with the supervisorycontrol algorithm reviewing the therapy commands of the new controlalgorithm over a transition period to ensure a bumpless transition fromthe previous control algorithm to the new control algorithm.

In an embodiment, a method of providing diabetes therapy to a patientwith an ambulatory infusion pump includes first delivering medicament tothe patient according to a first medicament delivery control algorithmand then altering delivery of the medicament to being determined by asecond medicament delivery control algorithm. Upon altering delivery ofthe medicament to being determined by the second medicament deliverycontrol algorithm, a temporary third algorithm comprising a supervisorypredictive low glucose suspend algorithm can be activated. Thesupervisory predictive low glucose suspend algorithm can reviewmedicament delivery commands determined by the second medicamentdelivery control algorithm and selectively prevent or enable executionof the medicament delivery commands based on the review. The supervisorypredictive low glucose suspend algorithm can be deactivated uponexpiration of a transition period.

According to embodiments, a smartphone or other remote device cancontrol a variety of infusion pump types, from a single manufacturer ormultiple manufacturers, using one or more control algorithms accessedfrom the cloud rather than directly from the pump and/or pumpmanufacturer and via protocols that are standardized to interface withthe communications software and equipment resident on the particularinfusion pump. The pump can track all medicament delivery made with thepump and share certain therapy parameters with connected remote controlalgorithms in order for such remote control algorithms to have accuratedata for safely making therapy determinations.

In one embodiment, an ambulatory infusion pump includes a defaultmedicament delivery algorithm thereon that makes therapy determinationsand causes the pump to provide therapy to a patient based on thosedeterminations. During pump operation, the pump maintains acurrent-state-file that is continually updated to track critical datarelating to the patient's therapy. The pump can selectively connect witha remote device, such as a smartphone, to be controlled by a remotemedicament delivery algorithm executed on the remote device. Uponestablishing a connection with a remote algorithm, the pump transfersthe current-state-file to the remote device to enable the remotealgorithm to utilize the data in the file to make accurate and safetherapy determinations. As the pump is controlled by the remote device,the current-state-file continues to be updated for later use by thedefault algorithm or a different remote device and/or remote algorithm.If the pump becomes disconnected from the remote algorithm, the pump canautomatically revert back to the default algorithm.

The above summary is not intended to describe each illustratedembodiment or every implementation of the subject matter hereof. Thefigures and the detailed description that follow more particularlyexemplify various embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

Subject matter hereof may be more completely understood in considerationof the following detailed description of various embodiments inconnection with the accompanying figures, in which:

FIG. 1 depicts an embodiment of a pump system according to thedisclosure.

FIG. 2 depicts a block diagram representing an embodiment of a pumpsystem according to the disclosure.

FIGS. 3A-3C depicts an embodiment of a pump system according to thedisclosure.

FIGS. 4A-4B depict an embodiment of a pump system according to thedisclosure.

FIG. 5 depicts an embodiment of a pump system according to thedisclosure.

FIGS. 6A-6B depict remote control devices for a pump system according toembodiments of the disclosure.

FIG. 7 depicts a system for switching between medicament deliverycontrol algorithms according to embodiments of the disclosure.

FIG. 8 depicts a flowchart of a method of switching between medicamentdelivery control algorithms according to embodiments of the disclosure.

FIG. 9 depicts a flowchart of a method of switching between medicamentdelivery control algorithms according to embodiments of the disclosure.

FIG. 10 depicts a flowchart of a supervisory PLGS algorithm according toembodiments of the disclosure

While various embodiments are amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the claimedinventions to the particular embodiments described. On the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the subject matter as defined bythe claims.

DETAILED DESCRIPTION OF THE DRAWINGS

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

FIG. 1 depicts an exemplary medical device that can be used withembodiments of the present invention. In this embodiment, the medicaldevice is configured as a pump 12. Pump 12 may be an infusion pump thatincludes a pumping or delivery mechanism and reservoir for deliveringmedicament to a patient and an output/display 44. The type ofoutput/display 44 may vary as may be useful for a particularapplication. The output/display 44 may include an interactive and/ortouch sensitive screen 46 having an input device such as, for example, atouch screen comprising a capacitive screen or a resistive screen. Thepump 12 may additionally include a keyboard, microphone, or other inputdevice known in the art for data entry, which may be separate from thedisplay. The pump 12 may also include a capability to operatively coupleto one or more blood glucose meters (BGMs) or continuous blood glucosemonitors (CGMs) and/or one or more secondary display devices such as aremote display, a remote control device, a laptop computer, personalcomputer, tablet computer, a mobile communication device such as asmartphone, a wearable electronic watch or electronic health or fitnessmonitor, or personal digital assistant (PDA), a CGM display etc.

The one or more other display devices may be configured to be used inplace of output/display 44 or to work in connection with output/display44 such that information may be repeated in exact or similar fashionbetween output/display 44 and one or more other displays, such thatdifferent information may be repeated between/among output/display 44and one or more other display devices, or such that information ispresented solely on one or more other display devices. Such one or moreother display devices may also include the capability to allow a user toinput information and/or commands for operation of the infusion pump,including, for example., via a touchscreen, microphone, keyboard orother input devices as are known in the art.

In one embodiment, the medical device can be an ambulatory pumpconfigured to deliver insulin to a patient. Further details regardingsuch pump devices can be found in U.S. Pat. No. 8,287,495, which isincorporated herein by reference in its entirety. In other embodiments,the medical device can be an infusion pump configured to deliver one ormore additional or other medicaments to a patient. In a furtherembodiment, the medical device can be a glucose meter such as a BGM orCGM. Further detail regarding such systems and definitions of relatedterms can be found in, e.g., U.S. Pat. Nos. 8,311,749, 7,711,402 and7,497,827, each of which is hereby incorporated by reference herein inits entirety. FIG. 2 illustrates a block diagram of some of the featuresthat can be used with embodiments of the invention, including featuresthat may be incorporated within the housing 26 of a medical device suchas a pump 12. The pump 12 can include a processor 42 that controls theoverall functions of the device. The infusion pump 12 may also include,e.g., a memory device 30, a transmitter/receiver 32, an alarm 34, aspeaker 36, a clock/timer 38, an input device 40, a user interfacesuitable for accepting input and commands from a user such as acaregiver or patient, a drive mechanism 48, an estimator device 52 and amicrophone (not pictured). One embodiment of a user interface as shownin FIG. 2 is a graphical user interface (GUI) 60 having a touchsensitive screen 46 with input capability. In some embodiments, theprocessor 42 may communicate with one or more other processors withinthe pump 12 and/or one or more processors of other devices, for example,a continuous glucose monitor (CGM), display device, smartphone, etc.through the transmitter/receiver. The processor 42 may also includeprogramming that may allow the processor to receive signals and/or otherdata from one or more input devices, such as sensors that may sensepressure, temperature and/or other parameters.

FIGS. 3A-3C depict another pump system including a pump 102 that can beused with embodiments of the invention. Drive unit 118 of pump 102includes a drive mechanism 122 that mates with a recess in disposablecartridge 116 of pump 102 to attach the cartridge 116 to the drive unit118 and provide for delivery of medicament such as insulin from thecartridge 116 to a user through a cannula. Further details regardingsuch pumps can be found in U.S. patent application Ser. No. 14/707,851filed May 8, 2015 and U.S. Patent Publication Nos. 2016/0339172 and2017/0049957, each of which is hereby incorporated herein by referencein its entirety.

In one embodiment, pump 102 includes a processor that controlsoperations of the pump and, in some embodiments, may receive commandsfrom a separate device for control of operations of the pump. Such aseparate device can include, for example, a dedicated remote control ora smartphone or other consumer electronic device executing anapplication configured to enable the device to transmit operatingcommands to the processor of pump 102. In some embodiments, theprocessor can also transmit information to one or more separate devices,such as information pertaining to device parameters, alarms, reminders,pump status, etc. In one embodiment, pump 102 includes a light source,such as a light emitting diode (LED) 174, that can indicate various pumpinformation and status.

As depicted in the embodiment of FIGS. 4A-4B, pump system 100 caninclude a pump 102 and an infusion set 145. FIG. 4A depicts thisinfusion set 145 as not connected to pump while FIG. 4B depicts infusionset 145 connected to pump 102 via connectors 154 and 152. Infusion set145 can include tubing 144 extending between a connector 154 and a siteconnector 146. Connector 154 can be configured to couple to pump 102 atconnector 152. Site connector 146 can be configured to be attached to aninfusion site on a user, while pump 102 can be carried in a separatelocation, such as the user's pocket (as depicted in FIG. 5) or anotherlocation on the user's body. Various lengths of tubing 144 can be usedin this embodiment to accommodate the user's preference.

Referring to FIGS. 5-6B, one or more remote control devices 170, 171 canbe used to communicate with the processor of pump 12 and/or pump 102 tocontrol delivery of medicament and transfer data with pump via a wiredor a wireless electromagnetic signal, such as via, e.g., a near fieldcommunication (NFC) radio frequency (RF) modality or other RF modalitiessuch as Bluetooth®, Bluetooth® low energy, mobile or Wi-Fi communicationprotocols, for example, according to embodiments of the presentdisclosure. Such a remote control can include, for example, a mobilecommunication device 170, such as a smart phone (as depicted in FIG. 5)executing a software application for control of the pump, a dedicatedremote controller 171 (as depicted in FIGS. 6A-6B), a wearableelectronic watch or electronic health or fitness monitor or personaldigital assistant (PDA), etc., or a tablet, laptop or personal computer.Such communications between (and among) the one or more remote controldevices 170, 171 and pump 102 may be one-way or two-way for, e.g.,effective transfer of data among the devices and the pump, control ofpump operations, updating software on the devices and/or pump, andallowing pump-related data to be viewed on the devices and/or pump.

As noted above, some users of ambulatory infusion pumps would like to beable to individually select a software control algorithm themselves forexecution by such a remote control device rather than solely employing asoftware control algorithm provided by the manufacturer of the infusionpump. Currently, however, use of such third party algorithms introducesadditional concerns. For example, third party algorithms may not havebeen tested by the pump manufacturer, either for efficacy of treatmentor for compatibility with a given pump and there is therefore a riskthat the algorithm will not provide proper treatment. In addition, analgorithm downloaded onto the pump from a remote source may not have hadprior access to patient data and could therefore initiate therapyinconsistent with the patient's recent therapy. Embodiments of thepresent invention provide safe and effective methods to enable asoftware algorithm being executed on a remote control device to takecontrol of an infusion pump as well as to switch between various controlalgorithms. In embodiments, these methods can include utilizing the pumpto track parameters related to patient therapy and to share such datawith a remote control algorithm to enable the algorithm to have accuratedata needed for proper therapy determinations.

FIG. 7 depicts various components of such a system 200 according to anembodiment. System components can include, for example, a user-wearableinfusion pump 202, a remote control device 204, remote data storage 206such as the cloud and one or more optional peripheral devices 208. Inthe depicted embodiment the remote control device 204 obtains data andinformation from the cloud, such as a medicament delivery controlalgorithm and communicates control commands and/or information to theinfusion pump 202 and receives data and information from the infusionpump 202. Alternatively or additionally, the infusion pump 202 maycommunicate with the cloud 206 and the remote control device can obtainpump data through the cloud 206. As noted above, a remote control 204can include, for example, a mobile communication device, such as a smartphone executing a software application for control of the pump, adedicated remote controller, a wearable electronic watch or electronichealth or fitness monitor or personal digital assistant (PDA), etc., ora tablet, laptop or personal computer. Optional peripheral devices, suchas a continuous glucose monitor 208 and corresponding sensor, can alsoprovide data to the remote control device 204 for use by the medicamentdelivery control algorithm to make therapy determinations. Suchperipheral devices can alternatively or additionally include, forexample, one or more of a blood glucose meter or other analyte sensingdevice, an activity or other health monitor, etc.

FIG. 8 depicts a flowchart of an embodiment of a method 300 for safelyswitching between medicament delivery control algorithms. At step 302,the pump operates according to the default medicament delivery controlalgorithm stored on the pump that is automatically used by defaultwhenever a remote medicament delivery control algorithm is not in use.As the pump is operated, a current-state-file for the device iscontinually updated at step 304. The pump is the only element of thesystem capable of tracking all medicament delivery made with the pumpand therefore the pump must track certain parameters in order forsubsequent remote control algorithms to have accurate data for safelymaking therapy determinations. Parameters tracked by the pump andincluded in the current-state-file include, for example, medicamentdelivery history, including bolus and basal medicament delivery history,glucose history, including data received from a CGM or BG meter, userentered BG values, etc., insulin on board, meal and exercise inputs andother patient profile settings.

At step 306, a connection is established between the pump and a remotecontrol device seeking to control the pump with a remote medicamentdelivery control algorithm. The current-state-file for the pumpmaintained by the pump is then transferred to the remote control deviceat step 308 for use by the remote algorithm in making therapydeterminations. This is necessary because the remote control algorithmcannot properly provide therapy to the patient without knowingparameters such as, e.g., the patient's typical basal rates, the currentestimated insulin on board in the patient, etc. The pump then proceedswith being operated by the remote control device according to the remotemedicament delivery control algorithm at step 310 with the pumpcontinuing to update the current-state-file for the pump based on thetherapy provided by the remote control device at step 312. The pump atstep 314 continually checks to ensure that the pump is connected to theremote control device and that therapy commands are being received fromthe device, and, if so, the pump continues to be operated by the remotecontrol device. If the connection is no longer present and/or no therapycommands are being received, then the pump automatically defaults backto the default on-board algorithm at step 302 using thecurrent-state-file as updated during remote control. This could occur,for example, if the wireless connection between the devices is severed,if the user manually stops the remote control algorithm, etc. Inaddition, although the above method describes switching from the defaulton-board algorithm to a remote control algorithm, similar steps would betaken to switch from a first remote control algorithm directly to asecond remote control algorithm.

With the foregoing systems and methods, a remote control device such asa smartphone can control a variety of different types of medicamentinfusion pumps, from a single manufacturer or multiple differentmanufacturers, using one or more medicament delivery control algorithmsaccessed from the cloud rather than directly from the pump and/or pumpmanufacturer. Each algorithm would be standardized to interface with thecommunications software, equipment and protocols of the particularinfusion pump.

Although the above description relates to using multiple softwarealgorithms for control of an infusion pump from one or more remotesources, there may be one or more available software control algorithmsresident on the pump itself (or on a remote control device) that theuser may be able to switch among and/or the processor may automaticallyswitch among under various conditions. As such, a current-state-fileincluding various parameters relating to medicament delivery with afirst algorithm can be shared with and/or accessed by a second algorithmin order to ensure safe switching between algorithms operable on such adevice, similar to the method described with respect to FIG. 8.

In addition, embodiments of the invention can provide additionalsafeguards when switching between control algorithms. Different controlalgorithms may calculate doses based on different factors, which can beproblematic when transitioning between algorithms. For example, a firstcontrol algorithm may incorporate logic to predict future glucose levelsand dose medicament based on those predictions whereas a second controlalgorithm may only dose based on current CGM glucose level readings. Insuch a situation, a user may consume a meal while operating the firstalgorithm and the algorithm may then deliver increased amounts ofmedicament (e.g., 5 units) based on a prediction that the user's glucoselevels will be too high in the future due to the meal. If the user thenswitches to the second algorithm, the second algorithm may see thecurrent glucose levels rise following consumption of the meal—withoutknowing that the first algorithm delivered a dose that is yet to takeeffect—and deliver a dose based on the current glucose level (e.g., 4units). The net result may be that the user is dosed twice for the sameevent and receives nearly double the medicament (e.g., 9 units insteadof 5 units) because the control algorithm was changed mid-therapy. Thus,changing control algorithms—whether between control algorithms alreadystored on a single device or between different remotely obtained controlalgorithms—can cause unintended side effects, such as the above examplewhere the user is double-dosed for a single event.

Embodiments described herein can therefore employ additional controllogic for managing the transition between control algorithms in additionto the control algorithm logic in order to ensure a smooth or “bumpless”transition between control algorithms. In embodiments, the transitioncontrol logic can be managed in two distinct and complementary ways.First, the therapy state of the previous control law, i.e., thecurrent-state-file as described above, is passed over to and/or accessby the new control law as the new control algorithm initiates control ofthe therapy. In the above-described example that resulted in doubledosing, the current-state-file would indicate to the new controlalgorithm that the current condition relating to a rise in blood glucosefrom a meal had already been addressed with an increased dose. Second,the transition control logic can employ an additional predictive lowglucose suspend (PLGS) feature that supervises the transition over atransition period of time. The supervising PLGS feature has the optionof negating any command from the new control algorithm to dosemedicament over the transition period if the glucose level of the useris trending low and the PLGS feature predicts that the glucose levelwill fall below a low threshold in the future (e.g., within 30 minutes).In this embodiment, the supervisory feature relates only to low glucoselevels such that the new control algorithm would be free to reduceinsulin as necessary as determined by the algorithm and dosing increasecommands issued at higher and/or increasing glucose levels that do notimplicate the low threshold would not be negated.

In an embodiment, the transition period over which the PLGS featuresupervises the dosing decisions of the new control algorithm is apredetermined time period, such as, for example one hour. In otherembodiments, the transition period can be based on the performance ofthe new control algorithm. For example, the PLGS feature may track astability of glucose levels of the user after the new control algorithmtakes control of therapy and may continue to supervise the algorithmuntil glucose levels meet predefined stability criteria. Such criteriacan include, for example, maintaining the glucose levels within apredetermined range for a predetermined period of time.

FIG. 9 depicts a flow chart of a method 400 for safely switching betweenmedicament delivery control algorithms according to an embodiment. Atstep 402, the pump is operated according to a first control algorithm.In an embodiment, the first control algorithm is one of a plurality ofcontrol algorithms stored on and/or accessible by the pump and/or withaccess to the pump. At step 404, therapy state information is maintainedby the pump while therapy is determined by the first control algorithm.Pump control is switched to a second control algorithm at step 406. Invarious embodiments, the second control algorithm can be selected by theuser or automatically switched to by the processor based on certainpredetermined events or criteria.

When the system is switched to control by the second control algorithmat step 406, both steps 408 and 410 can be carried out. In step 408, thesecond algorithm is provided with and/or accesses the therapy stateinformation, which can include, for example, recent therapydeterminations made by the first control algorithm such as decisions toincrease or decrease delivery of medicament. A supervisory PLGS featurecan also be activated when the second algorithm is selected at step 410.As noted above, at step 412 the PLGS feature can be an algorithm thatmonitors CGM data and therapy commands generated by the second controlalgorithm over a transition period. The PLGS feature can generallyenable commands that decrease the amount of insulin delivered and willonly negate commands to increase the amount of insulin if it isdetermined from the CGM data that the user's glucose level is likely togo below a low glucose threshold in the near future. The PLGS featuresupervises the second control algorithm until the end of the transitionperiod is reached at step 414. In embodiments, the transition period canbe a predefined amount of time or can be based on other data, such as,for example, a measure of stability of the user's glucose levels whiletherapy is under control of the second algorithm. Once the end of thetransition period is reached, the PLGS feature can be disabled at step416 and the second algorithm can continue controlling therapy withoutthe supervisory feature.

Referring now to FIG. 10, a flowchart of a method 500 of operation of asupervisory PLGS feature according to an embodiment in the context ofdelivery of insulin is depicted. At step 502 the supervisory PLGSalgorithm is activated. As noted above, this can be done in response tothe system switching from one therapy control algorithm to anothertherapy control algorithm. The supervisory PLGS algorithm can reside onthe device, e.g., a pump, and be activated and deactivated as needed.Upon activation, at step 504 the supervisory PLGS algorithm issuperimposed onto the therapy control algorithm to monitor insulindelivery commands calculated by the control algorithm. The deliverycommands are first reviewed at step 506 to determine if they reduce orincrease the amount of insulin being delivered to the user. If it isdetermined that the delivery command reduces the amount of insulin beingdelivered, the command is allowed to be executed at step 508, becausethe PLGS feature is provided only to supervise and prevent potential lowblood glucose levels and reduction of insulin is intended to raise bloodglucose levels. In other embodiments, the supervisory PLGS feature canbe adapted for use with other medicaments alternatively or in additionto insulin. In such cases, any medicament delivery adjustment, orcombination of medicaments, intended to raise blood glucose levels wouldbe allowed to be executed.

If the command reviewed at step 506 is one that increases insulindelivery, the PLGS algorithm reviews the user's recent CGM data and/orCGM trends at step 510 to determine if the command is permissible. Todetermine if the command is permissible, the PLGS algorithm determinesif the user's blood glucose level is predicted to go below a lowthreshold at step 512. If the user's blood glucose level is predicted togo low, the PLGS algorithm intervenes in the control algorithm to negateand prevent the delivery of the therapy command at step 514. If theuser's blood glucose level is not predicted to go low, the PLGSalgorithm allows the command to be executed. The determination that theuser's blood glucose level is predicted to go low can be based onvarious different information and determined in various differentmanners. Information reviewed can include, for example, one or more ofCGM glucose levels, CGM trends, blood glucose values entered by theuser, predicted future glucose levels, past and scheduled insulindelivery, the insulin delivery command currently under review, etc. Inone embodiment, the PLGS algorithm determines from CGM trends whether ornot the user's glucose level will be below a low threshold apredetermined time, e.g., 30 minutes, in the future.

In a further embodiment, a supervisory PLGS feature such as describedherein could be employed any time a remotely obtained, third-partyalgorithm such as those described above is employed. This would providean additional safety feature with regard to third party algorithms toensure these algorithms can run interrupted without violating the safetyconditions governed by the PLGS feature.

Although the embodiments herein have been specifically described withrespect to an ambulatory infusion pump, the inventions disclosed hereincould be employed with any other type of programmable medical devicecapable of receiving and executing remote commands. Such devicesinclude, for example, implantable pumps, defibrillators, spinal cordstimulation systems, etc. Embodiments could further include non-medicalapplications.

Although the infusion pump embodiments herein are specifically describedprimarily with respect to the delivery of insulin, delivery of othermedicaments, singly or in combination with one another or with insulin,including, for example, glucagon, pramlintide, etc., as well as otherapplications are also contemplated. Device and method embodimentsdiscussed herein may be used for pain medication, chemotherapy, ironchelation, immunoglobulin treatment, dextrose or saline IV delivery,treatment of various conditions including, e.g., pulmonary hypertension,or any other suitable indication or application. Non-medicalapplications are also contemplated.

Also incorporated herein by reference in their entirety are commonlyowned U.S. Pat. Nos. 6,999,854; 8,133,197; 8,287,495; 8,408,4218,448,824; 8,573,027; 8,650,937; 8,986,523; 9,173,998; 9,180,242;9,180,243; 9,238,100; 9,242,043; 9,335,910; 9,381,271; 9,421,329;9,486,171; 9,486,571; 9,492,608; 9,503,526; 9,555,186; 9,565,718;9,603,995; 9,669,160; 9,715,327; 9,737,656; 9,750,871; 9,867,937;9,867,953; 9,940,441; 9,993,595; 10,016,561; 10,201,656; 10,279,105;10,279,106; 10,279,107; 10,357,603; and 10,357,606. commonly owned U.S.Patent Publication Nos. 2009/0287180; 2012/0123230; 2013/0053816;2014/0276420; 2014/0276423; 2014/0276569; 2014/0276570; 2016/0082188;2017/0142658; 2017/0182248; 2017/0250971; 2018/0021514; 2018/0071454;2019/0240398; and 2019/0307952 and commonly owned U.S. patentapplication Ser. Nos. 16/423,675 and 16/507,146.

Further incorporated by reference herein in their entirety are U.S. Pat.Nos. 8,601,465; 8,502,662; 8,452,953; 8,451,230; 8,449,523; 8,444,595;8,343,092; 8,285,328; 8,126,728; 8,117,481; 8,095,123; 7,999,674;7,819,843; 7,782,192; 7,109,878; 6,997,920; 6,979,326; 6,936,029;6,872,200; 6,813,519; 6,641,533; 6,554,798; 6,551,276; 6,295,506; and5,665,065.

Various embodiments of systems, devices, and methods have been describedherein. These embodiments are given only by way of example and are notintended to limit the scope of the claimed inventions. It should beappreciated, moreover, that the various features of the embodiments thathave been described may be combined in various ways to produce numerousadditional embodiments. Moreover, while various materials, dimensions,shapes, configurations and locations, etc. have been described for usewith disclosed embodiments, others besides those disclosed may beutilized without exceeding the scope of the claimed inventions.

Persons of ordinary skill in the relevant arts will recognize that thesubject matter hereof may comprise fewer features than illustrated inany individual embodiment described above. The embodiments describedherein are not meant to be an exhaustive presentation of the ways inwhich the various features of the subject matter hereof may be combined.Accordingly, the embodiments are not mutually exclusive combinations offeatures; rather, the various embodiments can comprise a combination ofdifferent individual features selected from different individualembodiments, as understood by persons of ordinary skill in the art.Moreover, elements described with respect to one embodiment can beimplemented in other embodiments even when not described in suchembodiments unless otherwise noted.

Although a dependent claim may refer in the claims to a specificcombination with one or more other claims, other embodiments can alsoinclude a combination of the dependent claim with the subject matter ofeach other dependent claim or a combination of one or more features withother dependent or independent claims. Such combinations are proposedherein unless it is stated that a specific combination is not intended.

Any incorporation by reference of documents above is limited such thatno subject matter is incorporated that is contrary to the explicitdisclosure herein. Any incorporation by reference of documents above isfurther limited such that no claims included in the documents areincorporated by reference herein. Any incorporation by reference ofdocuments above is yet further limited such that any definitionsprovided in the documents are not incorporated by reference hereinunless expressly included herein.

For purposes of interpreting the claims, it is expressly intended thatthe provisions of 35 U.S.C. § 112(f) are not to be invoked unless thespecific terms “means for” or “step for” are recited in a claim.

The invention claimed is:
 1. A method of providing diabetes therapy to apatient with an ambulatory infusion pump, comprising: determiningmedicament delivery commands for delivery of medicament to the patientwith the ambulatory infusion pump according to a first medicamentdelivery control algorithm; delivering medicament to the patient withthe ambulatory infusion pump according to the medicament deliverycommands determined by the first medicament delivery control algorithm;altering delivery of the medicament from being determined according tothe first medicament delivery control algorithm to being determined by asecond medicament delivery control algorithm; upon altering delivery ofthe medicament to being determined by the second medicament deliverycontrol algorithm, activating a temporary third algorithm, the temporarythird algorithm comprising a supervisory predictive low glucose suspendalgorithm; reviewing medicament delivery commands determined by thesecond medicament delivery control algorithm with the supervisorypredictive low glucose suspend algorithm, the supervisory predictive lowglucose suspend algorithm selectively preventing or enabling executionof the medicament delivery commands based on the review; anddeactivating the supervisory predictive low glucose suspend algorithmupon expiration of a transition period.
 2. The method of claim 1, whereselectively preventing or enabling execution of the medicament deliverycommands includes: enabling execution of all medicament deliverycommands that would increase a blood glucose level of the user;preventing execution of medicament delivery commands that would reduce ablood glucose level of the user when it is predicted by the supervisorypredictive low glucose suspend algorithm that the blood glucose level ofthe user is likely to drop below a low glucose threshold.
 3. The methodof claim 2, where selectively preventing or enabling execution of themedicament delivery commands includes enabling execution of medicamentdelivery commands that would reduce a blood glucose level of the userwhen it is predicted by the supervisory predictive low glucose suspendalgorithm that the blood glucose level of the user is not likely to dropbelow a low glucose threshold.
 4. The method of claim 1, wherein thesupervisory predictive low glucose suspend algorithm selectivelyprevents or enables execution of the medicament delivery commands basedon the review of the medicament delivery commands and on data obtainedfrom a continuous glucose monitor.
 5. The method of claim 4, wherein thedata reviewed from the continuous glucose monitor includes glucose leveltrends of the user and supervisory predictive low glucose suspendalgorithm predicts future glucose levels based on the glucose leveltrends.
 6. The method of claim 1, wherein the transition period is apredetermined amount of time and deactivating the supervisory predictivelow glucose suspend algorithm upon expiration of the transition periodincludes deactivating after the predetermined amount of time haselapsed.
 7. The method of claim 1, wherein the transition period isbased on a stability of glucose levels of the user following delivery ofthe medicament with the second medicament delivery control algorithm anddeactivating the supervisory predictive low glucose suspend algorithmupon expiration of the transition period includes deactivating after itis determined that glucose levels of the user are stable.
 8. The methodof claim 1, further comprising receiving a user selection of the secondmedicament delivery control algorithm and delivery of the medicament isaltered from being determined according to the first medicament deliverycontrol algorithm to the second medicament delivery control algorithm inresponse to the user selection.
 9. The method of claim 1, whereindelivery of the medicament is automatically altered from beingdetermined according to the first medicament delivery control algorithmto the second medicament delivery control algorithm based on occurrenceof a predetermined event.
 10. The method of claim 1, further comprisingstoring pump parameters relating to delivery of medicament with thefirst medicament delivery control algorithm and wherein the secondmedicament delivery control algorithm utilizes the stored pumpparameters in determining delivery of the medicament.
 11. A method ofproviding diabetes therapy to a patient with an ambulatory infusionpump, comprising: delivering medicament to the patient with theambulatory infusion pump according to a first medicament deliveryalgorithm; monitoring pump parameters while delivering medicamentaccording to the first medicament delivery algorithm; storing themonitored pump parameters while delivering medicament according to thefirst medicament delivery algorithm in a current state file in a memory;establishing a connection with a second medicament delivery algorithmoperating on a remote device for replacing the first medicament deliveryalgorithm to deliver medicament to the patient with the ambulatoryinfusion pump; transferring the current state file from memory to theremote device for use by the second medicament delivery algorithm; andenabling medicament to be delivered according to the second medicamentdelivery algorithm after transferring the current state file to theremote device.
 12. The method of claim 11, wherein the first medicamentdelivery algorithm is a default medicament delivery control algorithmstored on the ambulatory infusion pump.
 13. The method of claim 12,further comprising automatically reverting to the default medicamentdelivery control algorithm if the connection with the second medicamentdelivery algorithm is disconnected.
 14. The method of claim 11, furthercomprising: monitoring pump parameters while delivering medicamentaccording to the second medicament delivery algorithm; updating thecurrent state file in the memory with the monitored pump parameterswhile delivering medicament according to the second medicament deliveryalgorithm.
 15. The method of claim 14, further comprising: establishinga connection with a third medicament delivery algorithm operating on theremote device for replacing the second medicament delivery algorithm todeliver medicament to the patient with the ambulatory infusion pump;transferring the current state file from memory to the remote device foruse by the third medicament delivery algorithm; and enabling medicamentto be delivered according to the third medicament delivery algorithmafter transferring the current state file to the remote device.
 16. Themethod of claim 11, further comprising downloading the second medicamentdelivery algorithm onto the remote device.
 17. The method of claim 16,wherein the second medicament algorithm is downloaded onto the remotedevice from an entity other than the manufacturer of the ambulatoryinfusion pump.
 18. The method of claim 11, wherein the parameters storedin the current state file include one or more of medicament deliveryhistory, glucose history and insulin on board.
 19. The method of claim11, further comprising activating a supervisory predictive low glucosesuspend algorithm, the supervisory predictive low glucose suspendalgorithm selectively preventing or enabling execution of medicamentdelivery commands determined by the second medicament delivery controlalgorithm for a temporary transition period of time.
 20. The method ofclaim 19, wherein the supervisory predictive low glucose suspendalgorithm prevents execution of medicament delivery commands that wouldreduce a blood glucose level of the user when it is predicted by thesupervisory predictive low glucose suspend algorithm that the bloodglucose level of the user is likely to drop below a low glucosethreshold.